Jerry Michaels

Jerry Michaels brings his dual expertise in psychology and communications to help healthcare clients prepare for crucial scientific meetings, media interviews, and crisis public relations. Jerry excels at developing communication strategies, analyzing the strengths of presenters, and coaching them to maximize their performance. With a Master’s Degree in Psychology from New York University, Jerry has created and conducted programs on case-based learning, healthcare provider and patient communication, effective product launches, and crisis communications. He has taught the Psychology of Communication courses at NYU’s Graduate School, and has conducted seminars on Crisis Communication for the Wharton School of Business at the University of Pennsylvania, Association of American Medical Colleges, and Duke University.

It is the current policy of the US Food and Drug Administration (FDA) to convene expert Advisory Committees to provide input on key regulatory decisions regarding opioid products, including approval and labeling of opioid abuse-deterrent formulations (ADFs). Advisory Committee meetings on ADF opioids consider whether the laboratory and clinical data…

Getting Approval for Abuse-Deterrent Opioids in the Era of an Opioid Epidemic

February 14, 2018

More than 42,000 Americans died from an opioid overdose in 2016. The number of deaths each year from opioids now surpasses the number of Americans who died each year from AIDS at the height of that epidemic in the mid-1990s. While misuse and abuse of prescription opioid medications is a…

The Debrief on Briefing Documents: How to Maximize Your Briefing Book for FDA Advisory Committee Meetings

December 7, 2017

At an FDA Advisory Committee (ADCOM) meeting – one of the most important days in a product’s development – Sponsors typically have no more than 75 minutes to credibly and persuasively explain their entire development program. The stakes are high because the committee plays a key role in influencing the…

The New FDA Focus: “Business as Usual” Now Includes Paying Attention to the Cost of Drug Development

October 19, 2017

In the “old days” (aka, last year), the FDA rarely mentioned the “cost of drug development.” The line between research and development (R&D) costs and regulatory was clear and not to be breached. And when the term “price” entered the vernacular, FDA officials were consistent in their message that the…